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Spinal Cord Stimulation for Parkinson's Disease (SCS for FOG Trial)
N/A
Recruiting
Led By Nora Vanegas, MD
Research Sponsored by Nora Vanegas-Arroyave
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least one witnessed freezing event during the screening visit in the 'on' medication state (defined as 45 minutes after a regular dose of Levodopa for the subject being studied)
Optimized PD treatment including dopaminergic medications and/or deep brain stimulation (DBS) therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-months
Awards & highlights
SCS for FOG Trial Summary
This trial will assess the effectiveness of SCS for treating FOG in PD patients. The investigators hope to find that SCS decreases the number of FOG episodes experienced by patients with PD.
Who is the study for?
This trial is for adults over 18 with Parkinson's Disease who have optimized their treatment but still experience at least two episodes of freezing gait daily that don't improve with medication. They must meet specific criteria for PD diagnosis and be able to consent. Excluded are those with certain psychiatric illnesses, uncontrolled medical conditions, or on anticoagulants they can't stop before the procedure.Check my eligibility
What is being tested?
The study tests if spinal cord stimulation (SCS) can reduce episodes of freezing gait in Parkinson's patients when standard treatments fail. It will compare two SCS programming methods to see how they affect motor skills, nonmotor symptoms, and life quality.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects of SCS may include discomfort at the implant site, unwanted tingling or sensations due to electrical impulses, infection risk from surgery, and possible changes in blood pressure.
SCS for FOG Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experienced freezing while moving, even after taking my regular Levodopa dose.
Select...
I am receiving the best possible treatment for Parkinson's, including medications or DBS.
Select...
I have Parkinson's with symptoms not improved by levodopa, including slow movement, tremor, or stiffness.
SCS for FOG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and Tolerability
Secondary outcome measures
10-meter walk
Change in MDS-UPDRS score
Change in New Freezing of Gait Questionnaire (NFOG-Q) score
+3 moreSCS for FOG Trial Design
2Treatment groups
Experimental Treatment
Group I: Spinal Cord Stimulation (SCS) Tonic stimulationExperimental Treatment1 Intervention
Tonic stimulation
Group II: Spinal Cord Stimulation (SCS) Burst stimulationExperimental Treatment1 Intervention
Burst stimulation.
Find a Location
Who is running the clinical trial?
Nora Vanegas-ArroyaveLead Sponsor
Nora VanegasLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Nora Vanegas, MDPrincipal InvestigatorBaylor College of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe mental health issues that could affect my study participation.I am on blood thinners and cannot stop them for 7 days before a procedure.I experienced freezing while moving, even after taking my regular Levodopa dose.I am receiving the best possible treatment for Parkinson's, including medications or DBS.I experience at least two episodes daily where my medication doesn't help my freezing of gait.I have severe, ongoing pain in my back or leg after surgery, or I have CRPS.I do not have an active infection, uncontrolled diabetes, or conditions that weaken my immune system.I am receiving the best possible treatment for Parkinson's, including medications or DBS.I have Parkinson's with symptoms not improved by levodopa, including slow movement, tremor, or stiffness.I am older than 18 years.
Research Study Groups:
This trial has the following groups:- Group 1: Spinal Cord Stimulation (SCS) Burst stimulation
- Group 2: Spinal Cord Stimulation (SCS) Tonic stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT03526991 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the scope of subjects involved in this research effort?
"Affirmative. Clinicaltrials.gov documents that this clinical investigation is currently looking for volunteers, with the trial having been first posted on August 1st 2021 and last modified April 18th 2022. 10 patients are sought from 2 distinct sites."
Answered by AI
Are there any available slots for participants in this trial?
"According to clinicaltrials.gov, this trial is currently searching for participants and was initially posted on August 1st 2021 with the last update occurring on April 18th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I know there's no cure for this disease but my quality of life is what I'm looking for. I have three grandchildren that I'd like to spend more time with and be able to interact with. I just want to feel comfortable in my skin again.
PatientReceived no prior treatments
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